Synthes (USA) Products, LLC: FDA filings under this applicant name
FDA lists 61 510(k) clearances under 2 spellings of the applicant name “Synthes (USA) Products, LLC” (first 2010, latest 2026), across 26 product codes in 5 review panels. Median 510(k) review time under this name: 112 days. Since 2017 the median was 124 days, against 101 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 106 |
| 2013 | 4 | 128 |
| 2014 | 10 | 134 |
| 2015 | 6 | 100 |
| 2016 | 3 | 147 |
| 2017 | 7 | 234 |
| 2018 | 4 | 205 |
| 2019 | 5 | 96 |
| 2020 | 6 | 116 |
| 2021 | 3 | 56 |
| 2022 | 1 | 135 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 175 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Synthes (USA) Products, LLC took a median 124 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 15 | 15 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 | 6 |
| HWC | Screw, Fixation, Bone | 5 | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| JEY | Plate, Bone | 3 | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 | 3 |
| MQN | External Mandibular Fixator And/Or Distractor | 3 | 3 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 2 |
Plus 16 more product codes.
Review panels
- Orthopedic (46)
- Dental (7)
- Neurology (6)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Synthes (USA) Products, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | KTT | 2026-06-11 | 175 |
| K212943 | SyntheCel Dura Repair | GXQ | 2022-01-28 | 135 |
| K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME) | KTT | 2021-05-25 | 25 |
| K210408 | DePuy Synthes Variable Angle Locking Patella Plating System | HRS | 2021-04-08 | 56 |
| K210205 | DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System | HRS | 2021-03-26 | 59 |
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm | HSB | 2020-09-23 | 125 |
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | GXN | 2020-09-18 | 357 |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | JEY | 2020-09-10 | 59 |
| K201578 | DePuy Synthes Variable Angle Locking Patella Plating System | HRS | 2020-09-09 | 90 |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm | JDS | 2020-09-03 | 106 |
51 earlier clearances. See the full list in Caduvo.
Recalls
164 product recalls in 72 recall events; 24 initiated in the last five years. Most recent: 2026-02-25.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Synthes (USA) Products, LLC (45)
- Synthes USA Products, LLC (16)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Synthes (Usa) (411 510(k)s)
- Synthes Spine (36 510(k)s)
- Synthes (19 510(k)s)
- Synthes Spine Co.Lp (18 510(k)s)
- Synthes GmbH (7 510(k)s)
- Synthes (Usa), LLC (7 510(k)s)
- Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. (5 510(k)s)
- Synthes (Usa) Products, LLC/Norian Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Synthes (USA) Products, LLC?
FDA lists 61 510(k) clearances under 2 spellings of the applicant name “Synthes (USA) Products, LLC” (first 2010, latest 2026), across 26 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Synthes (USA) Products, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synthes (USA) Products, LLC is 112 days. Since 2017: 124 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Synthes (USA) Products, LLC?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 15); HSB (Rod, Fixation, Intramedullary And Accessories, 6); HWC (Screw, Fixation, Bone, 5).
Next steps
- See all 61 Synthes (USA) Products, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRS, Synthes (USA) Products, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.